Trial Outcomes & Findings for Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer (NCT NCT01328249)

Last Updated: 2019-08-20

Results Overview

The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months

Results posted on

2019-08-20

Participant Flow

A total of 81 participants were enrolled out of which 2 participants did not receive eribulin mesylate and were excluded from the eribulin-treated analysis sets (79 participants made up the Eribulin-treated Analysis Set and Eribulin-treated Safety Analysis Set).

Participant milestones

Participant milestones
Measure	Cohort 1: Eribulin Mesylate With Filgrastim as Needed Participants initially received doxorubicin (60 milligram per square meter \[mg/m\^2\]) plus cyclophosphamide (600 mg/m\^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.	Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants \>60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
Overall Study STARTED	55	26
Overall Study COMPLETED	48	23
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Eribulin Mesylate With Filgrastim as Needed Participants initially received doxorubicin (60 milligram per square meter \[mg/m\^2\]) plus cyclophosphamide (600 mg/m\^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.	Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants \>60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
Overall Study Adverse Event	3	0
Overall Study Disease progression	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Moved before end of treatment visit	1	0
Overall Study Subject choice	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Eribulin Mesylate With Filgrastim as Needed n=55 Participants Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.	Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim n=26 Participants Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants \>60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.	Total n=81 Participants Total of all reporting groups
Age, Continuous	49.4 Years STANDARD_DEVIATION 9.09 • n=5 Participants	50.1 Years STANDARD_DEVIATION 9.33 • n=7 Participants	49.6 Years STANDARD_DEVIATION 9.12 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	26 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months

Population: The eribulin-treated analysis set included all participants who received at least 1 dose of eribulin mesylate at the starting dose of 1.4 mg/m\^2. This was the primary analysis set for the feasibility evaluation.

Outcome measures

Outcome measures
Measure	Cohort 1: Eribulin Mesylate With Filgrastim as Needed n=54 Participants Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.	Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim n=25 Participants Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants \>60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
Percentage of Participants With Feasibility	70.4 Percentage of participants Interval 58.5 to 80.4	60.0 Percentage of participants Interval 41.7 to 76.4

SECONDARY outcome

Timeframe: From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months

Population: The Safety Analysis Set included all participants who were enrolled, received at least 1 dose of study treatments and had at least 1 post-treatment safety assessment. This was the primary analysis set for all safety evaluations including issues related to cyclophosphamide and doxorubicin (AC) or eribulin treatments.

Safety assessments consisted of monitoring and recording all AEs and SAEs, clinical laboratory results, vital signs, physical examinations, Eastern Cooperative Oncology Group (ECOG) performance status, electrocardiograms (ECGs), and left-ventricular ejection fracture (LVEF) by multigated acquisition scan (MUGA) or echocardiogram. An AE was considered a treatment emergent adverse event (TEAE) if the AE onset date was on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related TEAEs included TEAEs that were considered by the Investigator to be possibly or probably related to eribulin mesylate and/or doxorubicin/cyclophosphamide, or missing causality. Standardized Medical Dictionary for Regulatory Activities Queries (SMQ).

Outcome measures

Outcome measures
Measure	Cohort 1: Eribulin Mesylate With Filgrastim as Needed n=55 Participants Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.	Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim n=26 Participants Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants \>60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) All TEAEs	55 Participants	26 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) AC-related TEAEs	55 Participants	26 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Eribulin-related TEAEs	54 Participants	23 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Grade ≥3 TEAEs	31 Participants	18 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) SAEs	6 Participants	4 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Alopecia	40 Participants	19 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Neutropenia (SMQ)	20 Participants	11 Participants
Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Peripheral neuropathy (SMQ)	40 Participants	15 Participants

Adverse Events

Cohort 1: Eribulin Mesylate With Filgrastim as Needed

Serious events: 6 serious events

Other events: 55 other events

Deaths: 3 deaths

Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Eribulin Mesylate With Filgrastim as Needed n=55 participants at risk Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) intravenously (IV) on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort growth factors, subcutaneous pegfilgrastim (6 mg) or filgrastim, could be used with eribulin therapy at the physician's discretion if neutropenia occurred that recovered to Grade ≤2.	Cohort 2: Eribulin Mesylate With Prophylactic Filgrastim n=26 participants at risk Participants initially received doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2) IV on Day 1, of every 14-day cycle for 4 cycles. Eribulin mesylate was administered following the doxorubicin plus cyclophosphamide regimen at a dose of 1.4 mg/m\^2 IV over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle for 4 cycles (Cycles 5 to 8). In this Cohort filgrastim was used with eribulin therapy at a dose of 300 micrograms for participants ≤60 kg or 480 micrograms for participants \>60 kg, administered subcutaneously on Days 3 and 4 and Days 10 and 11 of each eribulin cycle.
Blood and lymphatic system disorders Febrile neutropenia	3.6% 2/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	3.8% 1/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Gastrointestinal disorders Nausea	3.6% 2/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Gastrointestinal disorders Oesophagitis	3.6% 2/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Gastrointestinal disorders Vomiting	3.6% 2/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
General disorders Mucosal inflammation	0.00% 0/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	3.8% 1/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
General disorders Pyrexia	3.6% 2/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	3.8% 1/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Infections and infestations Breast abscess	0.00% 0/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	3.8% 1/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Infections and infestations Catheter site cellulitis	0.00% 0/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	3.8% 1/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Infections and infestations Genital herpes	1.8% 1/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Infections and infestations Lung infection	0.00% 0/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	3.8% 1/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Infections and infestations Upper respiratory tract infection	1.8% 1/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Investigations Weight decreased	1.8% 1/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Metabolism and nutrition disorders Dehydration	3.6% 2/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.
Nervous system disorders Syncope	1.8% 1/55 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.	0.00% 0/26 • From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were reported. AEs were graded on a 5-point scale according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. All SAEs were reported, no fatal AEs, and all SAEs have CTCAE grade less than (\<) 4. The safety analysis set consisted of participants who were enrolled, received at least 1 dose of study treatments, and had at least 1 post-treatment safety assessment.

Other adverse events

Additional Information

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Email: [email protected]

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